SASH: Sodium Accumulation Study In Haemodialysis

NCT05128188 | Completed

• 1 other identifier: UHDB/2021/020
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Haemodialysis (HD) sustains life in patients with end-stage kidney disease (ESKD) but is associated with a marked increase in incidence of cardiovascular disease (CVD) and high annual mortality rates. The pathogenesis of CVD in patients on HD is multifactorial and complex but hypertension is thought to be a major contributing factor. Sodium balance is normally regulated by the kidneys in health but has to be achieved by sodium removal during HD for those with ESKD. Recent evidence suggests that accumulation of sodium in the skin and / or muscle may be a critical factor impacting the development of hypertension and CVD in patients with ESKD and non-invasive methods are therefore required to study tissue sodium accumulation in this context. This study aims to determine the change in skin and muscle sodium content in patients undergoing haemodialysis. Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis).

Conditions

Haemodialysis; End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (2)

• Ascertainment of MRI measures of skin sodium content in 100% of patients studied

  Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.

  6 months

• Ascertainment of MRI measures of muscle sodium content in 100% of patients studied

  Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.

  6 months

Secondary Outcomes (4)

• To study skin sodium in haemodialysis patients and compare with previously reported healthy normal values

  6 months

• To study muscle sodium in haemodialysis patients and compare with previously reported healthy normal values

  6 months

• To measure degree of change in skin sodium content in relation to a single haemodialysis treatment

  6 months

• To measure degree of change in muscle sodium content in relation to a single haemodialysis treatment

  6 months

Study Arms (1)

Patients on haemodialysis

5 patients on haemodialysis will be recruited. The study involves a single dialysis session and two MRI scans (one prior and one following dialysis) and collection of clinical data.

Other: No intervention will be given in this study

Interventions

No intervention will be given in this study OTHER

No intervention will be given in this study

Patients on haemodialysis

Eligibility Criteria

• Age: 50 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

5 participants will be recruited from the renal unit

You may qualify if:

• Age 50-75 years inclusive
• Male patients with CKD stage 5 receiving chronic haemodialysis
• Patient has been dialysis dependent for at least 3 months
• Must be able to follow simple instruction in English (on safety ground for MRI scans) and be able to understand the nature and requirements of the study

You may not qualify if:

• Active infection or malignancy
• Amputee
• Pregnancy
• Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc
• Unable or unwilling to provide informed consent
• Medical conditions or overall physical frailty precludes scan session in opinion of investigator
• Any condition which could interfere with the patient's ability to comply with the study

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead

Study Sites (1)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, DE22 3NE, United Kingdom

Location

Study Officials

• Nicholas Selby, Professor

  University Hospitals of Derby and Burton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nephrology

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 19, 2021
• Study Start: March 1, 2022
• Primary Completion: August 2, 2023
• Study Completion: September 2, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)